BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 1842839 · Received September 17, 2010

    Report

    Report Number
    2210968-2010-01137
    Event Type
    Injury
    Date Received
    September 17, 2010
    Date of Event
    August 13, 2010
    Report Date
    August 17, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT AN AESTHETIC SURGERY PROCEDURE ON (B)(6) 2010 AND SUTURE WAS USED. SIX WEEKS POST-OPERATIVELY, THE SUTURES PERSISTED WITH LOCAL SUPPURATION. WITH LATE HEALING, THE WOUND CLOSED AND THEN RE-OPENED WITH SUPPURATION UNTIL THE SUTURE WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED VICRYL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE GAM ETHICON, INC. NA AD8GSHM0

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention